Antiphospholipid antibodies, APS
Conditions
Brief summary
The primary endpoint is a composite of three principal aPL-related adverse pregnancy outcomes: one or more pregnancy loss(es) (either < 10 weeks gestation or beyond 10 weeks of gestation of a morphologically normal fetus documented by ultrasound or by direct examination of the fetus) and premature birth of a morphologically normal neonate before 34 weeks due to any of: preeclampsia, eclampsia, recognized features of placental insufficiency
Detailed description
Pregnancy loss < 10 weeks gestation, Pregnancy loss > 10th week of gestation of a morphologically normal fetus documented by ultrasound or by direct examination of the fetus, Premature birth of a morphologically normal neonate < 34 weeks due to any of: pre-eclampsia, eclampsia, recognized features of placental insufficiency, Gestational age at delivery, Birth weight, Delivery by Caesarean section, Apgar score < 7 at 5 min, Neonatal morbidity (bleeding or thrombotic complications, infections, congenital abnormalities), Days to hospital discharge following delivery (mother & child), Thrombotic events in the mother during pregnancy and 6 weeks post-partum., Days of neonate in special care, Safety and tolerability of hydroxychloroquine in the mother and in the neonate
Interventions
DRUGThe placebo is a white
DRUGcircular
DRUGbiconvex tablet debossed with "200" on one side and plain on the other side
DRUGHydroxychloroquine sulfate 200 mg film-coated Tablets
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is a composite of three principal aPL-related adverse pregnancy outcomes: one or more pregnancy loss(es) (either < 10 weeks gestation or beyond 10 weeks of gestation of a morphologically normal fetus documented by ultrasound or by direct examination of the fetus) and premature birth of a morphologically normal neonate before 34 weeks due to any of: preeclampsia, eclampsia, recognized features of placental insufficiency | — |
Secondary
| Measure | Time frame |
|---|---|
| Pregnancy loss < 10 weeks gestation, Pregnancy loss > 10th week of gestation of a morphologically normal fetus documented by ultrasound or by direct examination of the fetus, Premature birth of a morphologically normal neonate < 34 weeks due to any of: pre-eclampsia, eclampsia, recognized features of placental insufficiency, Gestational age at delivery, Birth weight, Delivery by Caesarean section, Apgar score < 7 at 5 min, Neonatal morbidity (bleeding or thrombotic complications, infections, congenital abnormalities), Days to hospital discharge following delivery (mother & child), Thrombotic events in the mother during pregnancy and 6 weeks post-partum., Days of neonate in special care, Safety and tolerability of hydroxychloroquine in the mother and in the neonate | — |
Countries
Denmark, Ireland, Italy
Outcome results
None listed